NCT05512286

Brief Summary

This study is the first prospective randomized study assessing the patient-reported outcomes and safety outcomes between preoperative and postmastectomy radiotherapy in locally advanced breast cancer patients with immediate reconstruction of deep inferior epigastric perforator(DIEP) flap. Radiotherapy before mastectomy and autologous free-flap breast reconstruction can avoid adverse radiation effects on healthy donor tissues and delays to adjuvant radiotherapy. We aimed to explore the feasibility of preoperative radiotherapy followed by DIEP flap reconstruction in patients with breast cancer requiring mastectomy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
17mo left

Started Aug 2022

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Aug 2022Oct 2027

First Submitted

Initial submission to the registry

August 19, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 23, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

August 25, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

November 25, 2024

Status Verified

November 1, 2024

Enrollment Period

3.9 years

First QC Date

August 19, 2022

Last Update Submit

November 21, 2024

Conditions

Breast Cancer

Keywords

DIEP flapradiotherapybreast cancer

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction with breasts questionnaire Patient satisfaction of breast

    Patient satisfaction with breasts (as measured using the BREAST-Q reconstruction module) 24 months after surgery.

    24 months after surgery

Secondary Outcomes (7)

  • Complications of surgery

    3 months, 12 months, and 24 months

  • Complications of radiotherapy

    3 months, 12 months, and 24 months after radiotherapy

  • Failure rate of breast reconstruction surgery

    8 weeks after surgery

  • Patient satisfaction with outcome questionnaire

    3months, 12 months, and 24 months after surgery

  • Aesthetic evaluation

    12 months and 24 months after surgery

  • +2 more secondary outcomes

Study Arms (2)

Preoperative radiotherapy

EXPERIMENTAL

Radiotherapy followed by mastectomy and DIEP flap reconstruction

Radiation: Preoperative radiotherapy

Postmastectomy radiotherapy

ACTIVE COMPARATOR

Radiotherapy after mastectomy and DIEP flap reconstruction

Radiation: Postmastectomy radiotherapy

Interventions

Preoperative radiotherapyRADIATION

Radiotherapy followed by mastectomy and DIEP flap reconstruction

Preoperative radiotherapy
Postmastectomy radiotherapyRADIATION

Radiotherapy after mastectomy and DIEP flap reconstruction

Postmastectomy radiotherapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histological proven invasive breast cancer;
  • Clinical T0-3, T4b and N0-3a disease who require neoadjuvant chemotherapy;
  • No distant metastasis;
  • Adjuvant radiotherapy and who are suitable for DIEP flap reconstruction at the time of mastectomy.

You may not qualify if:

  • Patients enrolled in other clinical trial which may as influence the outcome;
  • Patients received neoadjuvant therapy without radiotherapy indications；
  • Disease progression during neoadjuvant chemotherapy；
  • Patients of pregnancy or lactation；
  • Previous history of diabetes；
  • Previous history of heavy smoking.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Guangxi Provincial Cancer Hospital

Nanning, Guangxi, 530021, China

RECRUITING

Henan Provincial Cancer Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

Hunan Provincial Cancer Hospital

Changsha, Hunan, 410031, China

RECRUITING

Huashan Hospital of Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Yunnan Provincial Cancer Hospital

Kunming, Yunnan, 650118, China

RECRUITING

Zhejiang Provincial Cancer Hospital

Hangzhou, Zhejiang, 310005, China

RECRUITING

Related Publications (1)

  • Hao S, Hou J, Zhang L, Zhou C, Hou Y, Yu K, Hu Z, Liu G, Di G, Shao ZM, Yu X, Wu J. Protocol for a multicentre, prospective, open-label, randomised controlled trial to compare PROs and safety outcomes between preoperative and postmastectomy radiotherapy in locally advanced breast cancer patients with immediate reconstruction via a deep inferior epigastric perforator flap (CAPPELLA) in China. BMJ Open. 2025 Jan 20;15(1):e086980. doi: 10.1136/bmjopen-2024-086980.

    PMID: 39832996DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jiong Wu

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiong Wu

CONTACT

862164175590wujiong1122@vip.sina.com

Shuang Hao

CONTACT

862164175590hzz50@hotmail.co,

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 19, 2022

First Posted

August 23, 2022

Study Start

August 25, 2022

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

October 1, 2027

Last Updated

November 25, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(6)